Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- GXOStrip, Craniosynostosis, Preformed2Product Code
- GXPMethyl Methacrylate For Cranioplasty2Product Code
- GXQDura Substitute2Product Code
- GXRCover, Burr Hole2Product Code
- GXTMonitor, Lesion Temperature2Product Code
- GWOPlate, Cranioplasty, Preformed, Alterable2Product Code
- GXCDevice, Electroconvulsive Therapy3Product Code
- GXNPlate, Cranioplasty, Preformed, Non-Alterable2Product Code
- GYZStimulator, Intracerebral/Subcortical, Implanted3Product Code
- GZAImplanted Cerebellar Stimulator3Product Code
- GZBStimulator, Spinal-Cord, Implanted (Pain Relief)2Product Code
- GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)2Product Code
- GZIStimulator, Neuromuscular, External Functional2Product Code
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief2Product Code
- HAXTong, Skull For Traction2Product Code
- HBPClip, Implanted Malleable2Product Code
- HBWFastener, Plate, Cranioplasty2Product Code
- HBZCatheter, Intravascular Occluding3Product Code
- HCBDevice, Aversive Conditioning2Product Code
- HCCDevice, Biofeedback2Product Code
- HCEClamp, Carotid Artery2Product Code
- HCGDevice, Neurovascular Embolization2Product Code
- HCHClip, Aneurysm2Product Code
- JXGShunt, Central Nervous System And Components2Product Code
- JXHMethyl Methacrylate For Aneurysmorrhaphy2Product Code
- JXICuff, Nerve2Product Code
- JXKCranial Electrotherapy Stimulator To Treat Depression3Product Code
- JXLBlock, Bite2Product Code
- LELDevice, Sleep Assessment2Product Code
- LHGElectrode, Spinal Epidural2Product Code
- LIHInterferential Current Therapy2Product Code
- K231575Vecttor VT-3002Cleared 510(K)
- K202725ETD40002Cleared 510(K)
- K183692Avid IF22Cleared 510(K)
- K122944GEMORE TRUE SINE INTERFERENTIAL STIMULATOR2Cleared 510(K)
- K121662VECTTOR VT-2002Cleared 510(K)
- K110509EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-9082Cleared 510(K)
- K100246MAX-IF10002Cleared 510(K)
- K092780INF 4160 PLUS, MODEL D-FJ31F2Cleared 510(K)
- K092763IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D2Cleared 510(K)
- K090023IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E2Cleared 510(K)
- K070890EVERLIFE INTERFERENTIAL CURRENT THERAPY, MODEL IF-1005072Cleared 510(K)
- K060975IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A22Cleared 510(K)
- K052289DEEPWAVE NEUROMODULATION PAIN THERAPY DEVICE2Cleared 510(K)
- K043407INF 4160, MODEL D-FJ27F2Cleared 510(K)
- K042057INFINITY ELECTROTHERAPY SYSTEM2Cleared 510(K)
- K040007INTERFERENTIAL STIMULATOR, MODEL BMLS02-62Cleared 510(K)
- K040824INTERFERENTIAL STIMULATOR, MODEL BMLS03-62Cleared 510(K)
- K032719GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)2Cleared 510(K)
- K033358CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-20002Cleared 510(K)
- K024100IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND2Cleared 510(K)
- K022433NEOGENESYS 2K2Cleared 510(K)
- K020516CARE IFC PLUS2Cleared 510(K)
- K013082MEDSTAR 100 INTERFERENTIAL STIMLATOR2Cleared 510(K)
- K003631SMARTWAVE IF 20002Cleared 510(K)
- K010948DYNATRON STS RX2Cleared 510(K)
- K010565DYNATRON STS2Cleared 510(K)
- K993600MULTI INTERFERENTIAL STIMULATOR, MODEL TR-8412Cleared 510(K)
- K992652SD-730 IF-SDS, PERFECT PULSE IF-SDS2Cleared 510(K)
- K990129TL250 INTERFERENTIAL/MUSCLE STIMULATOR INTERFERENTIAL CURRENT THERAPY MUSCLE STIMULATOR2Cleared 510(K)
- K974585IF-727 INTERFERENTIAL STIMULATOR2Cleared 510(K)
- K952683APEX MEDICAL CORP. PORTABLE INTERFERENTIAL STIMULATION DEVICE2Cleared 510(K)
- K961261DYNATRON 5252Cleared 510(K)
- K955860MULTI III, IV2Cleared 510(K)
- K955387ISOTRON III, ISOTRON IV2Cleared 510(K)
- K950349DYNATRON 9502Cleared 510(K)
- K950348DYNATRON 6502Cleared 510(K)
- K941577DYNATRON 5502Cleared 510(K)
- K941461DYNATRON 8502Cleared 510(K)
- K952089RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE2Cleared 510(K)
- K942428CMT-10002Cleared 510(K)
- K941815ISOTRON III2Cleared 510(K)
- K932868THERATOUCH 4.72Cleared 510(K)
- K930535IF4002Cleared 510(K)
- K930263MATRIX PRO-ELECDT2Cleared 510(K)
- K931732VIFI: VECTOR INTERFERENTIAL ONE2Cleared 510(K)
- K931768INTERFERENTIAL CURRENT THERAPY UNIT2Cleared 510(K)
- K930264MATRIX ELECDT & VACUPULLS2Cleared 510(K)
- K925687INTERFERENTIAL STIMULATOR MODEL IMF4150/A2Cleared 510(K)
- K924666INTELECT IFC22Cleared 510(K)
- K924961HMP 4000 INTERFERENTIAL STIMULATOR2Cleared 510(K)
- K924490MASTERSTIM I-22Cleared 510(K)
- K924319DYNATRON 4002Cleared 510(K)
- K922529POWERED MUSCLE STIMULATOR2Cleared 510(K)
- K922020ENDOMED 5822Cleared 510(K)
- K915100BRINDLEY & SMITH ET-10002Cleared 510(K)
- K921491MEDI-STIM2Cleared 510(K)
- K921954ISOTRON III2Cleared 510(K)
- K921953MULTI III2Cleared 510(K)
- K921612INTERTRON 4500, INTERTRON 5000, MASTERSTIM I-22Cleared 510(K)
- K921441INTERFERENTIAL STIMULATOR MODEL INF 4150/A2Cleared 510(K)
- K904743LSI SYSTEM II2Cleared 510(K)
- K905571ELECTRO-NERVE STIMULATOR TENS MODEL,INF 4150/A2Cleared 510(K)
- K883896NEUROTRAIN2Cleared 510(K)
- K883462IF-II (TM), MODEL 98002Cleared 510(K)
- K883080SYS*STIM 2202Cleared 510(K)
- K880924INTER TRON 40002Cleared 510(K)
- K870384ENDOMED 4332Cleared 510(K)
- K873566ELECTROSTIM I.F.2Cleared 510(K)
- K874119INTERFERENTIAL CURRENT UNIT2Cleared 510(K)
- K861039OMNIVAC (VACUUM ELECTRODE SYSTEM)2Cleared 510(K)
- K854721NEMECTRODYN MODEL 2 & ENDOVAC 22Cleared 510(K)
- K840321ENDODYNE DUAL2Cleared 510(K)
- K833305VECTOR SEIGE 2023645 AC POWERED STIMU-2Cleared 510(K)
- MVAOrthosis, Cranial2Product Code
- MYUAccessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty2Product Code
- MZQBalloon, Detachable, For Neurovascular Occlusion2Product Code
- NFOStimulator, Transcutaneous Electrical, Aesthetic Purposes2Product Code
- NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief2Product Code
- NUFCatheter, Neurovasculature, Occluding Balloon3Product Code
- NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2Product Code
- NYNStimulator, Electrical, Transcutaneous, For Arthritis2Product Code
- NYWStimulator, Nerve, Electrical, Transcutaneous, With Limited Output, For Pain Relief2Product Code
- NYXStimulator, Electrical, Transcutaneous, With Limited Output, For Aesthetic Purposes2Product Code
- OANOrthosis, Cranial, Laser Scan2Product Code
- OBPTranscranial Magnetic Stimulator2Product Code
- OBVEating Disorder Conditioning Tool2Product Code
- OCFStimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief2Product Code
- OKPTranscranial Magnetic Stimulator For The Treatment Of Migraine Headache2Product Code
- QMDTranscranial Magnetic Stimulation System For Smoking Cessation2Product Code
- OSGPiezo-Electric Stimulator For Relief Of Mosquito Bite Itch2Product Code
- PAVCatheter, Neuro-Vasculature, Occluding BalloonFProduct Code
- PBJCranial Distraction System2Product Code
- PCBExternal Cerebrospinal Fluid (Csf) Diversion2Product Code
- PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine2Product Code
- PJMFiller, Bone Void, Alterable Compound For Cranioplasty2Product Code
- PJNFiller, Bone Void, Non-Alterable Compound For Cranioplasty2Product Code
- PKRNon-Invasive Vagus Nerve Stimulator - Headache2Product Code
- PLUThermal System For Insomnia2Product Code
- POLNeurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment2Product Code
- PUUTemporary Coil Embolization Assist Device2Product Code
- PVLEndoscopic Shunt Placement Kit2Product Code
- PVOLumbar Drainage Catheter Kit2Product Code
- PWEComputerized Behavioral Therapy Device For Psychiatric Disorders2Product Code
- PZRPercutaneous Nerve Stimulator For Opioid Withdrawal2Product Code
- QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache2Product Code
- QARThermal Vestibular Stimulator For Headache2Product Code
- QBCExternal Upper Limb Tremor Stimulator2Product Code
- QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder2Product Code
- QFDTens For Sinus Pain2Product Code
- QFFElectromechanical Arm For A Transcranial Magnetic Stimulation System2Product Code
- QGHElectroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder2Product Code
- QGLTranscutaneous Nerve Stimulator For Adhd2Product Code
- QGTDistal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine2Product Code
- QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety2Product Code
- QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions2Product Code
- QQCBrain Stimulation Programming Planning Software.2Product Code
- QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder2Product Code
- OVPVibratory Counter-Stimulation2Product Code
- QVOComputerized Behavioral Therapy Device For Insomnia2Product Code
- SAPComputerized Behavioral Therapy Device For Depressive Disorders.2Product Code
- SCPComputerized Behavioral Therapy Device For Anxiety Disorders2Product Code
- SENBiofeedback For Adjunctive Treatment Of Symptoms Associated With Stress And Anxiety2Product Code
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
IF400
- Page Type
- Cleared 510(K)
- 510(k) Number
- K930535
- 510(k) Type
- Traditional
- Applicant
- SKYLARK DEVICE CO., LTD.
- Country
- Taiwan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/14/1994
- Days to Decision
- 497 days
- Submission Type
- Statement